Late Thrombosis of Drug-Eluting Stents: A Meta-Analysis of Randomized Clinical Trials

Bavry, Anthony A.; Kumbhani, Dharam J.; Helton, Thomas; Borek, Peter; Mood, Girish R.; Bhatt, Deepak L.

doi:10.1016/j.amjmed.2006.01.023

Cited by 443 publications

(238 citation statements)

References 26 publications

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“…27 For ''on-label'' indications (such as simple coronary stenosis), the benefits of DES outweigh their risks, the incidence of ST is low. 28 But for ''off-label'' (such as more complex coronary lesions) use of DES, the risk of ST is much higher than ''on-label'' use. 2,6,29 -32 In the real world, ''offlabel'' use accounts for 60%-75% of all procedures.…”

Section: Discussionmentioning

confidence: 99%

“…33 In fact, most of the patients enrolled in this study were ''off-label'' patients, so it was reasonable to get a higher ST rate than that of ''on-label'' patients. In an analysis of 14 studies including more than 6,000 patients, 28 the incidence of late and very late ST was about 1%. Most of these studies shared common exclusion criteria: low ejection fraction, acute myocardial infarction, renal failure, bifurcation lesions, or the need for multiple stents.…”

Section: Discussionmentioning

confidence: 99%

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Prolonged Dual Antiplatelet Therapy Improves Clinical Outcomes in High‐risk Patients Implanted with Sirolimus‐eluting Stents

Jia¹,

Zhou²,

Zhao³

et al. 2009

Clinical Cardiology

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BackgroundAlthough a science advisory recommending 12 months of dual antiplatelet therapy after drug‐eluting stents implantation was published recently, the optimal duration of dual antiplatelet therapy has not yet been precisely determined.HypothesisProlonged dual antiplatelet therapy can improve clinical outcomes in high‐risk patients implanted with sirolimus‐eluting stents.MethodsThe patients implanted with sirolimus‐eluting stents were assigned into standard clopidogrel therapy group (clopidogrel 75 mg/d for 12 mo) and prolonged clopidogrel therapy group (clopidogrel 75 mg/d for 18 mo). Long‐term aspirin (100 mg/d) therapy was adopted in both groups. The primary endpoint was very late stent thrombosis.ResultsAfter 12 months, 24 patients were excluded because of major adverse cardiovascular events (MACEs). Three hundred and thirty six patients surviving without MACEs were further followed up for 6 months. Between 12 and 18 months, in 160 patients with standard clopidogrel therapy, 5.6% had very late stent thrombosis. In contrast, in 176 patients with prolonged clopidogrel therapy, 1.1% had very late stent thrombosis (p < 0.01, versus standard clopidogrel therapy group).ConclusionsProlonged dual antiplatelet therapy may be beneficial to prevent very late stent thrombosis after sirolimus‐eluting stents implantation in high‐risk patients. Copyright © 2009 Wiley Periodicals, Inc.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Prolonged Dual Antiplatelet Therapy Improves Clinical Outcomes in High‐risk Patients Implanted with Sirolimus‐eluting Stents

Jia¹,

Zhou²,

Zhao³

et al. 2009

Clinical Cardiology

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“…A meta-analysis of over 6000 patients by Bavry et al, 2006, incorporating randomised controlled trials of paclitaxel stents versus bare metal stents (BMS) or sirolimus stents versus bare metal stents (BMS) indicated that the risk of late thrombosis is increased 4-5 fold in drug eluting stents after 6-12 months following revascularisation. In the analysis provided, the incidence of early thrombosis between DES and BMS was similar up to 1 month, beyond which there was a greater risk with DES1.…”

Section: Discussionmentioning

confidence: 99%

Very Late Stent Thrombosis Of A Cypher Stent And Review Of The Literature

Floros¹

2011

IJC

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We discuss a case of a 67 year old woman presented to the Emergency Department of the Gold Coast Hospital her initial angiogram however had ceased this 6 days prior to presentation in line with surgical advice prior to an expected colonoscopy. It was unknown as to why she was continuing to receive clopidogrel therapy and why she was not on dual antiplatelet therapy.Following the acquisition of the ECG the patient was subsequently transferred to the coronary catheter lab for primary percutaneous coronary intervention (PCI). Coronary catheterisation revealed a normal left main coronary artery (LMCA), some minor irregularities in the left anterior descending (LAD), minor disease in the circumflex artery but of greatest importance was Following acquisition of the ECG, the patient was transferred to the coronary catheter lab for primary PCI. This showed normal LMCA, minor irregularities in the LAD, minor disease in the circumflex but most importantly occlusion in a previously stented region in the RCA. The lesion was balloon-angioplastied without the requirement for further stenting. Angiographically a good result was obtained with no residual stenosis. The troponin I (cTnI) peaked at 3.4 micrograms per litre (normal range is less than 0.04 micrograms per litre).She had an uneventful recovery and a routine echocardiogram was performed following her angiography which showed preserved left ventricular systolic function. She was subsequently discharged on day 2 following her angioplasty. DiscussionLate stent thrombosis is a well known complication of drug eluting stents (DES) following revascularisation during coronary angiography. A meta-analysis of over 6000 patients by Bavry et al., 2006, incorporating randomised controlled trials of paclitaxel stents versus bare metal stents (BMS) or sirolimus stents versus bare metal stents (BMS) indicated that the risk of late thrombosis is increased 4-5 fold in drug eluting stents after 6-12 months following revascularisation. In the analysis provided, the incidence of early thrombosis between DES and BMS was similar up to 1 month, beyond which there was a greater risk with DES1. The median time to thrombosis observed through the study for sirolimus and paclitaxel stents respectively were 15.5 and 18 months, 11 and 14 months longer than late BMS thrombosis1. What still remains unclear is how long after revascularisation can thrombosis occur and currently there have been limited reports beyond 1 year of implantation.

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“…A meta-analysis of 14 randomized clinical trials involving 6,675 patients who received sirolimus and paclitaxel DES or bare metal stents (BMS) suggested that there may not be a safe interval after which clopidogrel may be discontinued. 19 In that analysis, 8 trials had more than 12 months of follow up. The incidence of late thrombosis occurring >1 year per 1,000 patients after the index procedure was substantially higher in DES patients compared with patients who received BMS ( Figure 5).…”

Section: Prevention Of Late Stent Thrombosis With Drug-eluting Stent mentioning

confidence: 99%

“…The incidence of late thrombosis occurring >1 year per 1,000 patients after the index procedure was substantially higher in DES patients compared with patients who received BMS ( Figure 5). 19 An observational analysis from the BAsel stent Kosten Effektivitäts Trial-LAte Thrombotic Events (BASKET-LATE) trial identified 746 patients who were without major adverse events 6 months after DES or BMS placement, and had discontinued clopidogrel. Although there were no differences in cumulative rates of death or MI between patients who received DES (versus BMS), higher rates of death and MI were observed after clopidogrel discontinuation in patients receiving DES (versus BMS; 4.9% versus 1.3%, respectively) at 18-month follow-up.…”

Section: Prevention Of Late Stent Thrombosis With Drug-eluting Stent mentioning

confidence: 99%

Clinical Considerations with the Use of Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention

et al. 2008

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Despite the proven benefits of using antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI), a number of key questions remain to be answered. In recent years, clopidogrel dosing strategies among such patients have evolved considerably, with newer approaches involving loading doses prior to PCI and increases in the time interval and loading dosage in an effort to overcome variable responsiveness/hyporesponsiveness to platelet inhibition. Further, the role of glycoprotein (GP) IIb/IIIa antagonists in elective stenting continues to be defined, with recent evidence suggesting that most appropriate use of these agents is in high‐risk patients with elevated troponin levels. There appears to be a relationship between the use of GP IIb/IIIa antagonists with clopidogrel loading and attenuation of early inflammatory and cardiac marker release. Strategies to minimize the chance of late stent thrombosis in patients who receive drug‐eluting stents (DES) are also under intense investigation. Among some patients receiving sirolimus and paclitaxel DES, current standard long‐term antiplatelet strategies may be insufficient. Patient nonadherence to treatment and premature discontinuation and underutilization of antiplatelet therapies by physicians remain important clinical problems with potentially dire consequences. Copyright © 2008 Wiley Periodicals, Inc.

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Late Thrombosis of Drug-Eluting Stents: A Meta-Analysis of Randomized Clinical Trials

Cited by 443 publications

References 26 publications

Prolonged Dual Antiplatelet Therapy Improves Clinical Outcomes in High‐risk Patients Implanted with Sirolimus‐eluting Stents

Prolonged Dual Antiplatelet Therapy Improves Clinical Outcomes in High‐risk Patients Implanted with Sirolimus‐eluting Stents

Very Late Stent Thrombosis Of A Cypher Stent And Review Of The Literature

Clinical Considerations with the Use of Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention

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